Effect of Pulmonary Recruitment Maneuver (PRM) on Pain and Nausea After Laparoscopic Cholecystectomy

NCT ID: NCT03026543

Last Updated: 2024-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2018-12-31

Brief Summary

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This prospective, blinded, randomized clinical trial investigates the effect on postoperative pain and nausea, when performing a ventilator-piloted PRM at the end of a laparoscopic cholecystectomy.

Detailed Description

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Conditions

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Pain, Postoperative Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Pulmonary recruitment maneuver

One minute of ventilator-piloted PRM at the end of laparoscopic cholecystectomy, intending to remove residual carbon dioxide (CO2) from the abdomen.

Group Type EXPERIMENTAL

Pulmonary Recruitment Maneuver

Intervention Type PROCEDURE

Laparoscopic cholecystectomy

Intervention Type PROCEDURE

Ventilator

Intervention Type DEVICE

Control group

Ordinary ventilation at the end of laparoscopic cholecystectomy.

Group Type ACTIVE_COMPARATOR

Laparoscopic cholecystectomy

Intervention Type PROCEDURE

Ventilator

Intervention Type DEVICE

Interventions

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Pulmonary Recruitment Maneuver

Intervention Type PROCEDURE

Laparoscopic cholecystectomy

Intervention Type PROCEDURE

Ventilator

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* elective laparoscopic cholecystectomy
* American Society of Anesthesiologists (ASA) physical status classification I-II (with the exception of body mass index over 35 kg/m2)
* written consent

Exclusion Criteria

* conversion to open surgery
* Clavien-Dindo grade ≥ II
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Östergötland

OTHER

Sponsor Role lead

Responsible Party

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Ebba Kihlstedt Pasquier

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ebba Kihlstedt Pasquier, MD

Role: PRINCIPAL_INVESTIGATOR

Vrinnevi Hospital, Norrköping, Sweden

Ellen Andersson, MD, PhD

Role: STUDY_CHAIR

Vrinnevi Hospital, Norrköping, Sweden

Locations

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Vrinnevi Hospital

Norrköping, Östergötland County, Sweden

Site Status

Countries

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Sweden

References

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Kihlstedt Pasquier E, Andersson E. Pulmonary Recruitment Maneuver Reduces Shoulder Pain and Nausea After Laparoscopic Cholecystectomy: A Randomized Controlled Trial. World J Surg. 2021 Dec;45(12):3575-3583. doi: 10.1007/s00268-021-06262-6. Epub 2021 Sep 5.

Reference Type RESULT
PMID: 34482412 (View on PubMed)

Other Identifiers

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Regionostergotland

Identifier Type: -

Identifier Source: org_study_id

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